This application describes an interlocking, two-site collaborative R01 to test the effects of a brief cognitive behavioral therapy (BCBT) protocol for youths (age 8-15) presenting with anxiety and/or depression in primary care. Over a five year period, 210 youths (105 per site) will be randomly assigned to (a) BCBT delivered in primary care or (b) enhanced referral to specialty mental health care (SMHC). This application builds on a preliminary study (N=60), in which a pilot version of BCBT was well-accepted by families and clinicians and was more efficacious than referral to SMHC. We now propose to test BCBT against an enhanced SMHC referral model in a larger, more diverse sample to establish its utility as a community-based intervention. Outcomes will be assessed by independent evaluators blind to participant status at 16 and 32 weeks post- randomization (Aim 1). It is hypothesized that BCBT will be superior to enhanced SMHC referral in terms of overall clinical improvement (CGI-I <2) and change in anxiety (PARS) and depression (CDRS-R) symptoms. Response also will be evaluated on brief self-report measures (SCARED, MFQ), as future community care may need to rely more heavily on these types of assessments. In addition, individual trajectories of participants will be examined to understand predictors of treatment response (Aim 2). It is hypothesized that severity of depression symptoms (youth and/or parent) will predict poorer response across treatments but that the BCBT program will still outperform the enhanced SHMC referral model. The effects of ethnicity also will be explored and use of two sites will allow greater enrollment of Hispanic (San Diego) and African-American (Pittsburgh) families than could be achieved by either in isolation. Targeting depression and anxiety as a unified problem area is innovative and in line with calls for new approaches to conceptualizing comorbidity and treating near neighbor disorders. Availability of an effective BCBT program for internalizing youths is needed as service settings struggle with limited sessions and resources available to train clinicians in multiple protocols. The application is noteworthy in adopting a deployment-focused model and testing this intervention early in its development within a real world context (primary care) and against a plausible public health comparision condition (enhanced SMHC referral) relevant for future treatment dissemination. Primary care has become a de facto site of mental health care delivery, with the possibilities of easier access, earlier identification and treatment, and prevention of chronicity. In line with this focus, data will be collected on the cost-effectiveness of the program (Aim 3) in order to lay the groundwork for future investigations focused on issues of dissemination, implementation, and real world sustainability. Site-unique contributions include expertise in practice-based research (San Diego) and data coordination (Pittsburgh). San Diego will serve as the overall coordinating site for the project.

Public Health Relevance

This study will test whether a brief (12 week) psychological treatment program, based in primary care, can help youths struggling with depression and anxiety. Impact of the program on symptoms and cost-effectiveness will be measured. This will be the first study to assess if anxiety and depression can be treated with one, simple program, and results may help move effective treatments for these serious problems into community practice.